Cerebral protection system

ABSTRACT

A cerebral protection system generally includes an array of cold packs, an insulating cover, and optionally a set of trays. The cold pack contains two reactive materials separated by a rupturable membrane. When the first reactive material and the second reactive material are mixed, an endothermic reaction occurs. The system can be used to induce hypothermia in selected regions of the brain when used. The system can be used to treat conditions including concussion, traumatic brain injury (TBI), heatstroke, cardiac arrest, respiratory arrest, anoxic brain injury, ischemic stroke, transient ischemic attack (TIA), or hypoxic ischemic encephalopathy.

RELATED APPLICATION

This application is a continuation-in-part of U.S. patent applicationSer. No. 14/774,599, filed Sep. 10, 2015, now U.S. Pat. No. 10,076,440,which is a 371 of PCT Application No. PCT/US2014/023579, filed Mar. 11,2014, which claims priority from U.S. Provisional Application Ser. No.61/779,930 which was filed on Mar. 13, 2013. The entirety of thatapplication is incorporated hereinto by reference.

BACKGROUND

The present disclosure relates to systems and methods for protecting thecerebral system. The systems and methods involve the production ofselective cerebral hypothermia to the brain to reduce injury.

Hypothermia is a condition that occurs when a body loses heat fasterthan it can produce heat, thereby causing a reduced body temperature. Inhumans, normal body temperature is around 98.6° F. (37° C.). Hypothermiamay occur as the body temperature passes below about 95° F. (35° C.).

Hypothermia is considered to be a medical emergency because the heart,nervous system, and other organs do not function normally. However,hypothermia is also a useful medical technique. Temperature reductionreduces metabolic activity, which can provide vital time to transportand treat patients. Cooling systems designed for use in hospitals maycost in the range of $20,000 to $30,000 and have maintenance costs.

Hospitals that use hypothermia target treatment within 6 hours of injurybecause such treatments have increased survival 23% to 48% according tostudies. It is desirable to begin treatment as early as possible.

Emergency medical services (EMS) units typically pick up patients andtake them to the nearest hospital for treatment. Some EMS units carryiced saline to infuse patients while in transport to the hospital. Suchinfusions do provide a reduction in patient temperature, but also havepotentially deleterious effects including hemoglobin reduction, fluidoverload, and time for IV insertion.

It would be desirable to develop new systems and methods for reducingthe likelihood and/or amount of damage caused by brain injuries shortlyafter a patient has suffered an injury.

BRIEF DESCRIPTION

The present disclosure relates to cerebral protection systems andmethods. The systems and methods are suitable for in-field generation ofselective hypothermia.

Disclosed in embodiments is a cerebral protection system which includesa first array of cold packs shaped to cover a first portion of a headand a second array of cold packs shaped to cover a second portion of thehead. The first array includes one or more first cold packs. Each firstcold pack contains a first reactive material, a second reactivematerial, and a first rupturable membrane separating the first reactivematerial from the second reactive material. The second array includesone or more second cold packs. Each second cold pack contains the firstreactive material, the second reactive material, and a second rupturablemembrane isolating the first reactive material from the second reactivematerial. The first reactive material and the second reactive materialare capable of reacting in an endothermic reaction when in contact.

In some embodiments, the first rupturable membrane and the secondrupturable membrane can be ruptured independently.

The first reactive material may be water and the second reactivematerial may be ammonium chloride.

Optionally, the cerebral protection system further includes twoearholes.

In some embodiments, the cerebral protection further includes aninsulating cover.

The cerebral protection system may further include a neck fastenershaped to extend from a first side of a front of a neck to a second sideof the front of the neck.

Optionally, the cerebral protection system further includes a chinfastener shaped to extend from a first area adjacent a first cheek ofthe head below a chin of the head to a second area adjacent a secondcheek of the head.

Disclosed in other embodiments is a cerebral protection system thatincludes a first array of cold packs shaped to cover a top, left portionof a head, a second array of cold packs shaped to left cheek andabove-left ear portions of the head, a third array of cold packs shapedto cover left neck and below-left ear portions of the head, a fourtharray of cold packs shaped to cover a top, right portion of the head, afifth array of cold packs shaped to cover right cheek and above-rightear portions of the head, and a sixth array of cold packs shaped tocover right neck and below-right ear portions of the head.

The first array includes one or more first cold packs. Each first coldpack contains a first reactive material, a second reactive material, anda first rupturable membrane separating the first reactive material fromthe second reactive material.

The second array includes one or more second cold packs, each secondcold pack containing the first reactive material, the second reactivematerial, and a second rupturable membrane isolating the first reactivematerial from the second reactive material.

The third array includes one or more third cold packs, each third coldpack containing the first reactive material, the second reactivematerial, and a third rupturable membrane isolating the first reactivematerial from the second reactive material.

The fourth array includes one or more fourth cold packs, each fourthcold pack containing the first reactive material, the second reactivematerial, and a fourth rupturable membrane isolating the first reactivematerial from the second reactive material.

The fifth array includes one or more fifth cold packs, each fifth coldpack containing the first reactive material, the second reactivematerial, and a fifth rupturable membrane isolating the first reactivematerial from the second reactive material.

The sixth array includes one or more sixth cold packs, each sixth coldpack containing the first reactive material, the second reactivematerial, and a sixth rupturable membrane isolating the first reactivematerial from the second reactive material.

The first reactive material and the second reactive material are capableof reacting in an endothermic reaction when in contact.

In some embodiments, the first rupturable membrane, the secondrupturable membrane, the third array rupturable membrane, the fourtharray rupturable membrane, the fifth rupturable membrane, and the sixthrupturable membrane can be independently ruptured.

The first reactive material can be water and the second reactivematerial can be ammonium chloride.

Optionally, the cerebral protection system includes a chin fastener. Thechin fastener includes a first portion attached to the second array anda second portion attached to the fifth array.

In some embodiments, the cerebral protection system further includes aneck fastener. The neck fastener includes a first portion attached tothe third array and a second portion attached to the sixth array.

The cerebral protection system may further include a first earholebetween the second array and the third array; and a second earholebetween the fifth array and the sixth array.

Optionally, the cerebral protection system further includes aninsulating cover located external to the first array, the second array,the third array, the fourth array, the fifth array, and the sixth array.

The cerebral protection system may further include front neck tabs andrear neck tabs.

In some embodiments, the cerebral protection system further includes arear slit and a rear fastener for accommodating a ponytail extendingfrom the head.

Optionally, the first array and the fourth array each have four coldpacks and the second array, the third array, the fifth array, and thesixth array each have three cold packs.

Disclosed in further embodiments is a cerebral protection systemincluding a first compartment containing a first reactive material, asecond compartment containing a second reactive material, and arupturable membrane separating the first compartment from the secondcompartment and isolating the first reactive material from the secondreactive material. The second reactive material is capable of reactingin an endothermic reaction with the first reactive material whencontacted with the first reactive material. The first compartment isshaped to at least partially cover the top of a head. The secondcompartment is shaped to at least partially cover a back of the head anda neck.

The first reactive material may be water and the second reactivematerial may be ammonium chloride.

Optionally, the cerebral protection system further includes aninsulating cover.

In some embodiments, the first compartment includes a foreheadprotrusion shaped to at least partially cover the area between eyes of apatient.

The second compartment may include an adjustable neck flap.

These and other non-limiting characteristics of the disclosure are moreparticularly disclosed below.

BRIEF DESCRIPTION OF THE DRAWINGS

The following is a brief description of the drawings, which arepresented for the purposes of illustrating the exemplary embodimentsdisclosed herein and not for the purposes of limiting the same.

FIG. 1 is a side view of a first exemplary embodiment of a cerebralprotection system of the present disclosure.

FIGS. 2A-2E are front, front perspective, side, rear perspective, andrear views, respectively, of a second exemplary embodiment of a cerebralprotection system of the present disclosure without a cover.

FIG. 3A-E are front, front perspective, side, rear perspective, and rearviews, respectively, of an embodiment of a cerebral protection system ofthe present disclosure with a cover.

FIG. 4A-4D are front, front perspective, rear, and rear perspectiveviews, respectively, of an embodiment of a cerebral protection system ofthe present disclosure with a cover and collar.

FIG. 5A-5D are front, side, rear perspective, and rear views,respectively, of an embodiment of a cerebral protection system of thepresent disclosure with a cover and a collar.

FIGS. 6A and 6B are side and rear views, respectively, of an embodimentof a cerebral protection system of the present disclosure whichillustrate how the system may be applied to a patient who has aponytail.

FIG. 7 illustrates an array of cooling packs which may be used inembodiments of a cerebral protection system of the present disclosure.

DETAILED DESCRIPTION

A more complete understanding of the components, processes andapparatuses disclosed herein can be obtained by reference to theaccompanying drawings. These figures are merely schematicrepresentations based on convenience and the ease of demonstrating thepresent disclosure, and are, therefore, not intended to indicaterelative size and dimensions of the devices or components thereof and/orto define or limit the scope of the exemplary embodiments.

Although specific terms are used in the following description for thesake of clarity, these terms are intended to refer only to theparticular structure of the embodiments selected for illustration in thedrawings, and are not intended to define or limit the scope of thedisclosure. In the drawings and the following description below, it isto be understood that like numeric designations refer to components oflike function.

The singular forms “a,” “an,” and “the” include plural referents unlessthe context clearly dictates otherwise.

Numerical values in the specification and claims of this applicationshould be understood to include numerical values which are the same whenreduced to the same number of significant figures.

All ranges disclosed herein are inclusive of the recited endpoint andindependently combinable (for example, the range of “from 2 grams to 10grams” is inclusive of the endpoints, 2 grams and 10 grams, and all theintermediate values).

A value modified by a term or terms, such as “about” and“substantially,” may not be limited to the precise value specified. Theapproximating language may correspond to the precision of an instrumentfor measuring the value. The modifier “about” should also be consideredas disclosing the range defined by the absolute values of the twoendpoints. For example, the expression “from about 2 to about 4” alsodiscloses the range “from 2 to 4.”

FIG. 1 illustrates a side view of an exemplary embodiment of a cerebralprotection system 100 of the present disclosure. The cerebral protectionsystem 100 includes an upper portion 112, a lower portion 114, and arupturable membrane 113 separating the upper portion 112 from the lowerportion 114. The cerebral protection system 100 includes earholes 110.The upper portion 112 optionally includes a forehead protrusion 105which is designed to extend into the area between the eyes. The lowerportion 114 includes a neck flap 116 which may be opened to apply thecerebral protection system 100 to a person and tightened or loosened fora good fit. Optionally, the cerebral protection system further includesan insulating cover (not shown here).

The upper portion 112 includes an upper compartment which contains afirst reactive material. The lower portion 114 includes a lowercompartment which contains a second reactive material. The firstreactive material and the second reactive material react endothermicallywhen in contact. The rupturable membrane 113 prevents mixing of thefirst reactive material and the second reactive material until themembrane 113 is ruptured. The membrane may be ruptured before or afterthe cerebral protection system 100 is placed on the human, thoughgenerally it is before placement. Upon rupture of the membrane 113, thefirst and second reactive materials are mixed and react endothermically.The endothermic reaction absorbs heat, thereby cooling the brain.

In other embodiments, the cerebral protection system of the presentdisclosure comprises a set of cold packs shaped to cover a human head,an insulating cover surrounding the set of cold packs, and optionally aset of trays for holding the cold packs. FIGS. 2A-E show one arrangementof the cold packs of the cerebral protection system 200. The insulatingcover is not shown in this set of pictures. Visible in these picturesare earholes 210 and a total of 20 cold packs 221-240, including 10left-side cold packs 221-230 and 10 right-side cold packs 231-240.

The 10 left-side cold packs 221-230 are arranged in three arrays. Thefirst array is shaped to cover a top, left portion of the head andincludes four cold packs 221, 222, 223, and 224. The second array isshaped to cover left cheek and above-left ear portions of the head andincludes three cold packs 225, 226, and 227. The third array is shapedto cover left neck and below-left ear portions of the head and includesthree cold packs 228, 229, and 230.

The 10 right-side cold packs 231-240 are also arranged in three arrays.The fourth array is shaped to cover a top, right portion of the head andincludes four cold packs 231, 232, 233, and 234. The fifth array isshaped to cover right cheek and above-right ear portions of the head andincludes three cold packs 235, 236, and 237. The sixth array is shapedto cover right neck and below-right ear portions of the head andincludes three cold packs 238, 239, and 240.

FIGS. 3A-3E illustrate the cerebral protection system 300 with theinsulating cover 345. The cerebral protection system includes aninsulating cover 345 which reduces/eliminates heat transfer from theexternal environment into the cerebral protection system 300. As seenhere, the insulating cover surrounds the cold packs (not shown), whichare within the interior of the insulating cover. The cover 345 itselfmay include an outer layer and an inner, insulating layer, the innerlayer contacting the cold packs or the set of trays. The outer layer maybe relatively thin. In some embodiments, the cover is formed from aplurality of panels. Each panel may be sized and shaped to cover a givenarray of cold packs, such as the arrays referred to in FIG. 2A-2E above.

The cover 345 includes left cheek cover portion 349, left top coverportion 350, left neck cover portion 351, right cheek cover portion 359,right top cover portion 360, and right neck cover portion 361. Thecerebral protection system 300 further includes ear holes 310, a chinfastener 347, a front neck fastener 353, and a rear neck fastener 355.The fasteners 347, 353, 355 are adjustable to permit easy applicationand removal of the cerebral protection system 300. The fasteners 347,353, 355 also permit a better fit by securing the cold packs inappropriate locations relative to the head. In this regard, the coldpacks can be attached to the interior of the insulating cover usingfasteners, without using the set of trays.

As best seen in FIG. 3C, the chin fastener 347 and the neck fastener 353reside in perpendicular planes when the cerebral protection system 300is secured to a patient's head. As best seen in FIG. 3E, all of thepanels 349, 350, 351, 359, 360, 361 meet along a horizontal seam at therear of the head. it is contemplated that the two neck cover portions351, 361 are not joined together, but rather form an open vertical seamthat runs up to the horizontal seam. Instead, the two neck coverportions are joined by the rear neck fastener 355. As seen later, thispermits long hair to be passed outside of the insulating cover 345.

FIGS. 4A-4D illustrate the flexibility of the cerebral protection system400 of the present disclosure. The cerebral cooling system 400 includesan insulating cover 445 including a cheek cover portion 449 and a neckcover portion 451, chin fastener 447, neck fastener 453, rear fastener455, and ear holes 410. Also visible is a neck collar 460, which is usedfor protecting the neck and spinal cord (e.g., during transport of apatient from an injury site to a hospital). As seen here, the neckfastener 453 can be opened to permit the neck collar 460 to fit beneaththe cerebral cooling system 400. Alternatively, the neck collar 460 canalso be a cold pack and used to cool the brain. The carotid artery runsnear the surface of the neck and the blood may be more easily cooled atthe neck.

FIGS. 5A-5D illustrate another means of using the cerebral protectionsystem. Here, the cerebral protection system 500 again includes aninsulating cover 545 including a cheek cover portion 549, chin fastener547, and ear holes 410. Here, the neck collar 560 is applied externallyto the cerebral protection system 500. Here, the cerebral protectionsystem is contemplated as being sized to be able to fit between theperson's neck and the neck collar.

FIGS. 6A and 6B illustrate the cerebral protection system 600 being usedon a person with long hair. The cover 645 includes left cheek coverportion 649, left top cover portion 650, left neck cover portion 651,right cheek cover portion 659, right top cover portion 660, and rightneck cover portion 661. The cerebral protection system 600 also includesa chin fastener 647 for securing cold packs (beneath the cover 645, notshown) in an appropriate arrangement. As seen here, the open seambetween neck cover portions 651, 661 and loosening of the rear neckfastener 655 permit a ponytail to extend through the cover 645.

FIG. 7 show the set of trays which can also be used with the cerebralprotection system 700. The set includes six trays 762, 764, 766, 768,770, 772. Each tray includes an open top, a bottom surface, and aplurality of compartments separated by walls 790. It is contemplatedthat a cold pack is placed within each compartment. As seen here, thewalls are scalloped to permit easier grasping of the cold pack in thecompartment. The trays can be made of a soft, pliable material. In someembodiments, the tray material is a good heat conductor.

The first tray 762 is shaped to cover a top portion of the head andincludes four compartments 721, 722, 723, and 724. The second tray 764is shaped to cover a cheek and above-ear portion of the head andincludes three compartments 725, 726, and 727. The third tray 766 isshaped to cover a neck and below-ear portion of the head and includesthree compartments 728, 729, and 730.

The fourth tray 768 is shaped to cover a top portion of the head andincludes four compartments 731, 732, 733, and 734. The fifth tray 770 isshaped to cover a cheek and above-ear portion of the head and includesthree compartments 735, 736, and 737. The sixth tray 772 is shaped tocover a neck and below-ear portion of the head and includes threecompartments 738, 739, and 740.

The first tray 762 is a reflection of the fourth tray 768. Put anotherway, if the first tray was held up to a mirror, the reflection would bein the shape of the fourth tray. Similarly, the second tray 764 is areflection of the fifth tray 770, and the third tray 766 is a reflectionof the sixth tray 772.

The first tray 762 and the fourth tray 768 can be described as having anarcuate shape covering an arc. The second tray 764 and the fifth tray770 can be described as having an outer perimeter that extends aboutthree-quarters of the circumference of a circle, and surrounding acentral cutout. The third tray 766 and the sixth tray 772 can bedescribed as being of a rectangular shape, with one corner being shapedto include an arc that completes the central cutout. The central cutoutforms an earhole.

In some embodiments, it is contemplated that cold packs are placedwithin each compartment of the set of trays. For example, the cold packsseen in FIG. 2B would be placed within the trays seen in FIG. 7. Eachcold pack contains the two different reactive materials separated by arupturable membrane, which react endothermically when mixed. In theseembodiments, the trays can be fastened to the insulating cover, so thatthe cold packs directly contact the patient's head. Alternatively, thetrays can be fastened to the insulating cover such that the cold packsare trapped between the bottom of the tray and the insulating cover, andthe tray bottom directly contacts the patient's head. In theseembodiments, the tray material should be a good heat conductor. Thus,for example, the first tray 768 may cover either the top right portionof the head, or the top left portion of the head, depending on how thecold packs and trays are arranged.

In some other embodiments, the reactive materials can be placed withinthe tray compartments, and the top of the tray would be sealed with afilm. Adjacent compartments would contain different reactive materialsand be isolated from each other. For example, the passageways 790 inFIG. 7 would be sealed by rupturable membranes. When the membranes areruptured, the reactive materials would be mixed and reactendothermically. The materials include two or more reactants and/orcatalysts. For example, in a tray including three compartments, eachcompartment may contain a different reactive material or catalyst,permitting the reaction to occur or to speed up the rate of thereaction.

In some embodiments, both of the reactive materials are present in asingle compartment, but the reaction kinetics are such that very littleheat is absorbed. In an adjacent compartment separated by a rupturablemembrane, a catalyst is present which increases the reaction ratesufficiently to absorb enough heat to selectively create a hypothermiceffect in at least a portion of a patient's brain upon rupture of themembrane.

The cover may include a thin outer layer and an inner insulation layer.The outer layer may be comprised of suitable materials. The insulationlayer includes one or more insulating materials. The insulating coverwould be attached to the trays using known fasteners or similar means.

The reactive materials causing the endothermic reaction are, inparticular embodiments, water and ammonium chloride. Other combinationsof materials that result in an endothermic reaction include water withammonium nitrate; water with potassium chloride; and ethanoic acid withsodium carbonate.

As illustrated here, a total of 20 cold packs and six trays are used tomake the cerebral protection system. The number of cold packs, and thenumber of trays, can be varied as desired. The number of compartments ineach tray can also be varied as desired.

The membranes in different trays may be ruptured independently. In otherwords, the endothermic reaction may be selectively induced in specificparts of the cerebral protection system. Selective rupturing of themembranes permits control of which areas of the brain (e.g., frontal,parietal, temporal, or occipital regions) are cooled. For example, toprevent/minimize damage to the left prefrontal cortex, membranes couldbe selectively ruptured on the top and front of the cerebral protectionsystem on the left side that will be adjacent to the relevant portion ofa patient's skull when the system is in use.

The fasteners described herein may be of any type of fastener including,but not limited to, hook and loop-type fasteners.

The cerebral protection system is in the shape of a helmet. Typically,patients with head trauma are lying down on a flat surface. It iscontemplated that the insulating cover can be opened and then slidunderneath the patient's head, then sealed together using the fasteners.If desired, the insulating cover can be made in two separate pieces andthen joined together with a large fastener across the top of theinsulating cover.

It is also contemplated that in some embodiments, the inner surface ofthe insulating cover contacting the patient's head may contain pouchesthat are shaped and arranged to hold cold packs in locationscorresponding to those described for the compartments in the trays. Somepouches are located to cover a top portion of the head, similar to thefirst tray and the four tray, and cover an arc. Some pouches are locatedto cover a cheek and above-ear portion of the head, like the second trayand the fifth tray, and together have an outer perimeter that extendsabout three-quarters of the circumference of a circle, and surrounds acentral cutout. Some pouches are located to cover a neck and below-earportion of the head, like the third tray and the sixth tray, andtogether have a rectangular shape, with one corner being shaped toinclude an arc that completes the central cutout. The central cutoutforms an earhole.

The cerebral protection system of the present disclosure has severalindications of use, or conditions which can be positively treated usingthe system. These conditions can be treated by applying the cerebralprotection system to the head of a patient experiencing the condition.Such conditions include concussion; traumatic brain injury (TBI);heatstroke; after cardiac arrest; after respiratory arrest; anoxic braininjury (e.g. caused by respiratory arrest); ischemic stroke; transientischemic attack (TIA); and hypoxic ischemic encephalopathy (which canlead to cerebral palsy in infants). Generally, reducing metabolicactivity is helpful in extending the time to obtain treatment for theseconditions, or reducing temperature is a means for treating such acondition. Concussions and concussion-like symptoms can be caused by ablow to the head, or by exposure to radio frequencies such asmicrowaves, or exposure to sonic waves. Traumatic brain injury is abroader category of injuries that can occur due to blows or jolts to thehead, including both physical contact (e.g. a first hitting the head)and non-physical contact (e.g. shock wave or overpressure from anexplosion). The cerebral protection system is applied for a suitabletime period as desired.

It will be appreciated that variants of the above-disclosed and otherfeatures and functions, or alternatives thereof, may be combined intomany other different systems or applications. Various presentlyunforeseen or unanticipated alternatives, modifications, variations orimprovements therein may be subsequently made by those skilled in theart which are also intended to be encompassed by the following claims.

The invention claimed is:
 1. A method for reducing metabolic activity of a patient, comprising: applying a cerebral protection system to the head of the patient, wherein the cerebral protection system comprises: an array of cold packs shaped to cover the head, each cold pack containing a first reactive material, a second reactive material, and a rupturable membrane separating the first reactive material from the second reactive material; wherein the first reactive material and the second reactive material are capable of mixing and reacting in an endothermic reaction when the rupturable membrane is ruptured; an insulating cover; and a plurality of trays, each tray comprising an open top, a bottom, a plurality of compartments therein, and walls separating the compartments, wherein each compartment is configured to receive a cold pack, and where each tray is configured for attachment to the insulating cover.
 2. The method of claim 1, wherein the first reactive material is water and the second reactive material is ammonium chloride.
 3. The method of claim 1, wherein the insulating cover includes a neck fastener shaped to extend from one side of the neck to the other side of the neck.
 4. The method of claim 1, wherein the insulating cover includes a chin fastener shaped to extend from a first area adjacent a first cheek of the head below a chin of the head to a second area adjacent a second cheek of the head.
 5. The method of claim 1, wherein a rear of the insulating cover includes an open vertical seam.
 6. The method of claim 1, wherein each tray fastens to the insulating cover such that the plurality of cold packs is located between the insulating cover and the bottom of the tray.
 7. The method of claim 1, wherein the plurality of trays comprises: a first tray and a fourth tray which are reflections of each other; a second tray and a fifth tray which are reflections of each other; and a third tray and a sixth tray which are reflections of each other; wherein the first tray, second tray, third tray, fourth tray, fifth tray, and sixth tray each contain a plurality of compartments; wherein the first tray has an arcuate shape; wherein the second tray has an outer perimeter that extends about three-quarters of the circumference of a circle, and surrounds a central cutout; wherein the third tray has a rectangular shape with one corner being shaped to include an arc that cooperates with the second tray to complete the central cutout and form an earhole; and wherein each tray compartment contains a cold pack.
 8. A method for treating concussion, traumatic brain injury (TBI), heatstroke, cardiac arrest, respiratory arrest, anoxic brain injury, ischemic stroke, transient ischemic attack (TIA), or hypoxic ischemic encephalopathy in a patient, comprising: applying a cerebral protection system to the head of the patient, wherein the cerebral protection system comprises: an array of cold packs shaped to cover the head, each cold pack containing a first reactive material, a second reactive material, and a rupturable membrane separating the first reactive material from the second reactive material, wherein the first reactive material and the second reactive material are capable of mixing and reacting in an endothermic reaction when the rupturable membrane is ruptured; an insulating cover; and a plurality of trays, each tray comprising an open top, a bottom, a plurality of compartments therein, and walls separating the compartments, wherein each compartment is configured to receive a cold pack, and where each tray is configured for attachment to the insulating cover.
 9. The method of claim 8, wherein the first reactive material is water and the second reactive material is ammonium chloride.
 10. The method of claim 8, wherein the insulating cover includes a neck fastener shaped to extend from one side of the neck to the other side of the neck.
 11. The method of claim 8, wherein the insulating cover includes a chin fastener shaped to extend from a first area adjacent a first cheek of the head below a chin of the head to a second area adjacent a second cheek of the head.
 12. The method of claim 8, wherein a rear of the insulating cover includes an open vertical seam.
 13. The method of claim 8, wherein the plurality of trays comprises: a first tray and a fourth tray which are reflections of each other; a second tray and a fifth tray which are reflections of each other; and a third tray and a sixth tray which are reflections of each other; wherein the first tray, second tray, third tray, fourth tray, fifth tray, and sixth tray each contain a plurality of compartments; wherein the first tray has an arcuate shape; wherein the second tray has an outer perimeter that extends about three-quarters of the circumference of a circle, and surrounds a central cutout; wherein the third tray has a rectangular shape with one corner being shaped to include an arc that cooperates with the second tray to complete the central cutout and form an ear hole; and wherein each tray compartment contains a cold pack.
 14. The method of claim 8, wherein the concussion is caused by a blow to the head, or exposure to radio frequencies, or exposure to sonic waves. 